Phase II Randomized controlled trial comparing conventionally fractionated radiation vs hypofractionated radiation in locally advanced non adeno non small cell carcinoma lung

PHASE II RANDOMIZED CONTROLLED TRIAL COMPARING NEOADJUVANT CHEMOTHERAPY FOLLOWED BY RADICAL RADIOTHERAPY vs. NEOADJUVANT CHEMOTHERAPY FOLLOWED BY HYPOFRACTIONATED RADIOTHERAPY CONCURRENT WITH CHEMOTHERAPY IN LOCALLY ADVANCED NON SMALL CELL LUNG CANCER (EXCEPT ADENOCARCINOMA)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/11/004143

Enrollment

Registered

2013-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cancer

Interventions

Intervention1: Neoadjuvant chemotherapy followed by hypofractionated radiation with concurrent chemotherapy.: 2 Cycles of neoadjuvant chemotherapy with Paclitaxel (200mg/m2 BSA) and Carboplatin (AUC 5

Eligibility

Inclusion criteria

Inclusion criteria: • Age less than 70 years. • Confirmed HPE report of squamous cell or large cell carcinoma of lung • Stage IIIA or IIIB • KPS 70 or more. • No prior treatment for lung cancer. • All baseline investigation report within normal limit as indicated below: 1. HAEMOGRAM: • Haemoglobin > 10 gram% • Platelets count > 100,000/ cmm • Total Leukocyte count > 4000/ cmm • Absolute neutrophil count > 1500/ cmm 2. LIVER FUNCTION TEST: • Total Bilirubin • SGOT • SGPT • ALP 3. KIDNEY FUNCTION TEST: • Blood urea • Serum Creatinine

Exclusion criteria

Exclusion criteria: • Age more than 70 years. • KPS less than 70. • Any previous history of malignancy • Synchronous malignancies • Uncontrolled diabetes mellitus, uncontrolled systemic hypertension, severe COPD, CHF or chronic kidney disease.

Design outcomes

Primary

Measure	Time frame
â?¢To assess the feasibility of using hypofractionated radiotherapy with concurrent chemotherapy in locally advanced non-small cell lung cancer. â?¢To assess and compare the loco regional response and progression free survival. â?¢To evaluate the utility of PET scan in response evaluation of locally advanced NSCLC. Timepoint: at 6 months	—

Secondary

Measure	Time frame
â?¢ To study and compare the toxicity of the two arms. â?¢ Assess quality of life of patients undergoing treatment in both arms following EORTC protocol no.QLQ - LC 13. â?¢ To compare the impact of overall treatment time in the management of locally advanced NSCLC (except adenocarcinoma). â?¢ To assess and compare the overall survival in both arms Timepoint: at 6 months	—

Countries

India

Contacts

Public ContactSoumyajit Roy

All India Institute of Medical Sciences

drspathy@rediffmail.com09811898793

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 13, 2026